Skip to content

ALLTM Set

by SG BioScience Inc. 14 variants

Ref T5004Model ATS 2

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-08800069150041 Basic UDI-DI 08800069150041UDI-DIDate20 Sep 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
ATS 2, T5004
Primary DI / UDI-DI
08800069150041
Basic UDI-DI
B-08800069150041
EMDN Code
A1102, W0104010203
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
KR-MF-000009362
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from SG BioScience Inc.

See all devices from SG BioScience Inc. →

Properties

  • Sterile
  • Reagent
  • Professional Testing

Other properties (7)

  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No